Assessment of the tolerance angle for pedicle screw insertion.

Cannulation process intervenes before implantation of pedicle screw and depends on the surgeon's experience. A reliable experimental protocol has been developed for the characterization of the slipping behavior of the surgical tool on the cortical shell simulated by synthetic materials. Three types of synthetic foam samples with three different densities were tested using an MTS Acumen 3 A/T electrodynamic device with a tri-axis 3 kN Kistler load cell mounted on a surgical tool, moving at a constant rotational speed of 10° mm-1 and performing a three-step cannulation test. Cannulation angle varied between 10° and 30°. Synthetic samples were scanned after each tests, and cannulation coefficient associated to each perforation section was computed. Reproducibility tests resulted in an ICC for Sawbone samples of 0.979 (p < 0.001) and of 0.909 (p < 0.001) for Creaplast and Sawbone samples. Cannulation coefficient and maximum force in Z-axis are found the best descriptors of the perforation. Angular threshold for perforation prediction was found to be 17.5° with an area under the curve of the Receiver Operating Characteristic of 89.5%. This protocol characterizes the cannulation process before pedicle screw insertion and identifies the perforation tool angle until which the surgical tool slips on the cortical shell depending on bone quality.

Sliding on cortical shell: Biomechanical characterization of the vertebral cannulation for pedicle screw insertion.

BACKGROUND: Pedicular screws pull-out has been well studied unlike their insertion. A need for characterizing cannulation before pedicle screw implantation is highlighted in literature and offers promising prospects for future intra-operation instrumentation. A reliable cannulation protocol for ex-vivo testing in swine and cadaver vertebrae is presented in this work to predict extra pedicular perforation. METHODS: An MTS Acumen 3 A/T electrodynamic device, with a tri-axis 3 kN Kistler load cell mounted on a surgical tool was used to reproduce surgeon's gesture by moving at a constant rotational speed of 10°/mm and performing a three-section test. Perforation of the pedicle's cortical shell was planned through a design of experiment on the surgical tool angle at the entry point. Samples were scanned before and after mechanical tests and reproducibility of the protocol was tested on synthetic foam. Computation of the angle between cannulation tool and pedicle cortical shell was performed as well as cannulation coefficient of each perforation section. FINDINGS: A total of 68 pedicles were tested: 19 perforated and 21 non-perforated human pedicles, 17 perforated and 16 non-perforated swine pedicles. The reproducibility of the protocol for cannulation coefficient computation resulted in an intraclass correlation coefficient of 0.979. Cannulation coefficients results presented variability within spinal levels as well as between swine and human model. Correlation between bone density and cannulation coefficient was found significant (p < 0.005). Torque measurement was found to be the best predictor of perforation. Threshold of angle for prediction of perforation was found to be 21.7°. INTERPRETATION: Characterizing pedicle cannulation enables to predict extra pedicular perforation. Influence of bone mineral density and patient-specific morphology on pedicle cannulation has been highlighted together with a comparison of swine and cadaver models.